Table 5 Evidence from reported cases (CIOMS VI, Appendix 7)

Positive rechallenge

No

Definitive (i.e., clearly defined, well documented specific case histories)

Yes

Time to onset plausible

Yes

Positive dechallenge

N/A

Lack of confounding risk factors

Yes

Amount and duration of exposure consistent/plausible with cause and effect

N/A

Corroboration of the accuracy of the case history

Yes

Case clear-cut, easily evaluated

Yes

Co-medication unlikely to play a role

Yes

Investigator’s causality assessment

Yes

Lack of alternative explanation

Yes